at-home subcutaneous immunoglobulin replacement therapy using alexa skill

Conditions: Primary Immunodeficiency Diseases (PID)

Summary: the main aim of this study is to determine the impact of digital health technology, such as alexa skill, used to support the initiation of home-based subcutaneous immunoglobulin (scig) treatment, treatment management, and overall participant experience.

this is a non-interventional, observational study to identify relevant concepts of scig treatment experience, as well as satisfaction regarding alexa skill-assisted scig initiation, infusion, and disease/therapy management. the study will enroll approximately 36 participants (26 patients/caregivers and 10 healthcare professionals \[hcps\]). participants will be enrolled into following observational cohorts: * adult patients with primary immunodeficiency (pid) * caregivers of patients with a self-reported diagnosis of pid * hcps who prescribe scig for patients with pid interviews will be conducted by a trained qualitative research interviewer with patients, caregivers, and hcps, and self-reported data will be collected. this trial will be conducted in the united states. the overall duration of the study will be approximately 4 months.

Eligibility criteria:
inclusion criteria: patients and caregivers: * adult patient (aged 18 years or older) with pid who recently initiated (within 4 months) or will soon initiate (within 30 days) hyqvia or cuvitru at home or caregiver (aged 18 years or older) supporting participants (any age) with pid who recently initiated (within 4 months) or will soon initiate (within 30 days) hyqvia or cuvitru at home. * patient has a self-reported physician diagnosis of pid. * resides in the us or us territories. * can speak and read english fluently. * able to participate in an interview(s). * must have a wireless network (wi-fi) at home (cannot be a wireless hotspot). * must have an existing amazon account. * must be willing to receive an amazon echo show device and connect the device to wi-fi. * must have a smartphone and be willing to download and use the alexa application to access the alexa skill test. additional criteria for patients and caregivers completing qualitative debriefing interviews: * must have at least 2 scig infusions (hyqvia or cuvitru) at a residential home or residential assisted living facility within 6 to12 weeks. * must attest to use of alexa skill to support at-home scig infusions. for hcps: * resides in the us or us territories. * must be an immunologist or registered nurse/nurse practitioner. * licensed to practice in the us. * can speak and read english fluently. * able to participate in a debriefing interview. * willing to provide informed consent. * must have a wireless network (wi-fi). * must have an existing amazon account. * must be willing to receive an amazon echo show device and connect the device to wi-fi. * must have a smartphone and be willing to download and use the alexa application to access the alexa skill test. * must attest to exploration of alexa skill as a support tool for patients and caregivers administering scig infusions at home. exclusion criteria • patients who were previously on scig and transitioned to either hyqvia or cuvitru scig product will be excluded.

Keywords: drug therapy